Stablomaks (Drops) Instructions for Use

ATC Code

S01GX09 (Olopatadine)

Active Substance

Olopatadine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

An antiallergic drug for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; decongestants and antiallergic agents; other antiallergic agents

Pharmacological Action

Selective blocker of histamine H₁-receptors. It is assumed that Olopatadine also inhibits the release of inflammatory mediators from mast cells. It has a pronounced antiallergic effect.

It prevents histamine-induced release of inflammatory cytokines in conjunctival epithelial cells.

It has no effect on α-adrenergic receptors, dopamine receptors, m₁– and m₂-cholinergic receptors, or serotonin receptors.

Pharmacokinetics

With topical application, systemic absorption is low. C_max of olopatadine in blood plasma is reached within 2 hours after topical application and ranges from 0.5 ng/ml or less to 1.3 ng/ml. T_1/2 in plasma is 3 hours. It is excreted mainly by the kidneys, 60-70% is excreted unchanged.

Indications

Depending on the drug used: seasonal allergic conjunctivitis; itchy eyes due to allergic conjunctivitis.

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye(s).

Administer twice daily at approximately 8-hour intervals for the management of allergic conjunctivitis.

Ensure an interval of at least 6-8 hours between applications.

Use the solution only in the eyes; do not inject or take orally.

Before use, wash your hands thoroughly.

Avoid allowing the dropper tip to contact any surface, including the eye, to prevent contamination of the solution.

If using other topical ophthalmic medications, maintain an administration interval of at least 5 minutes between them.

Apply eye gels or ointments last after all eye drop solutions.

The dosage regimen is the same for adults, geriatric patients, and pediatric patients 3 years of age and older.

No dosage adjustment is required for patients with hepatic or renal impairment.

If symptoms persist or worsen, consult a physician.

Adverse Reactions

Infections and infestations: uncommon – rhinitis.

Immune system disorders: frequency unknown – hypersensitivity to olopatadine, facial swelling.

Nervous system disorders: common – headache, dysgeusia; uncommon – dizziness, hypoaesthesia; frequency unknown – somnolence.

Eye disorders: common – eye pain, eye irritation, dry eye, abnormal sensation in eye; uncommon – corneal erosion, corneal epithelial defect, punctate keratitis, keratitis, accumulation of staining pigment in the area of corneal defect during diagnostic tests, eye discharge, photophobia, blurred vision, visual acuity reduced, blepharospasm, eye discomfort, eye pruritus, conjunctival folliculosis, conjunctival changes, foreign body sensation in eyes, lacrimation, eyelid erythema, eyelid edema, eyelid changes, conjunctival hyperemia; frequency unknown – corneal edema, conjunctival edema, conjunctivitis, mydriasis, visual impairment, crusting on eyelid margins.

Respiratory, thoracic and mediastinal disorders: common – dry mouth; frequency unknown – dyspnea, sinusitis.

Gastrointestinal disorders: frequency unknown – nausea, vomiting.

Skin and subcutaneous tissue disorders: uncommon – contact dermatitis, skin burning sensation, dry skin; frequency unknown – dermatitis, erythema.

General disorders and administration site conditions: common – fatigue; frequency unknown – asthenia, malaise.

Contraindications

Hypersensitivity to olopatadine, pregnancy, breastfeeding period, children under 3 years of age.

With caution

In patients with concomitant dry eye syndrome and corneal diseases.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

Dosage adjustment is not required.

Use in Renal Impairment

Dosage adjustment is not required.

Pediatric Use

Contraindicated in children under 3 years of age. Can be used in children aged 3 years and older in the same doses as in adults.

Geriatric Use

Dosage adjustment is not required.

Special Precautions

If severe hypersensitivity reactions occur, the use of olopatadine should be discontinued.

Effect on ability to drive vehicles and operate machinery

If a patient experiences temporary blurred vision after using olopatadine, it is not recommended to drive a car or engage in other activities requiring high concentration and speed of psychomotor reactions until vision is restored.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.